A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
8. september 2026 oppdatert av: Hoffmann-La Roche
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus
The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
300
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Studer Kontakt Backup
- Navn: Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.
- Telefonnummer: 888-662-6728 (U.S. Only)
- E-post: global-roche-genentech-trials@gene.com
Studiesteder
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Beijing, Kina, 100044
- Rekruttering
- Peking University People's Hospital
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Changchun, Kina, 130041
- Rekruttering
- The Second Hospital of Jilin University
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Hefei, Kina, 230601
- Rekruttering
- The Second Affiliated Hospital of Anhui Medical University
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Herbin, Kina, 150001
- Rekruttering
- The Fourth Affiliated Hospital of Harbin Medical University
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Huai'an, Kina
- Rekruttering
- Huai'an first people's hospital
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Huzhou, Kina, 313000
- Rekruttering
- Huzhou Central Hospital
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Jinan, Kina, 250013
- Rekruttering
- Jinan Central Hospital
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Langfang, Kina, 065000
- Rekruttering
- Hebei Petro China Central Hospital
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Luoyang, Kina, 471000
- Rekruttering
- Luoyang Third People's Hospital
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Nanjing, Kina, 211100
- Rekruttering
- The Affiliated Jiangning Hospital of Nanjing Medical University
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Shanghai, Kina, 200120
- Rekruttering
- Shanghai East Hospital
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Shanghai, Kina, 200072
- Rekruttering
- Shanghai Tenth People's Hospital
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Shanghai, Kina, 201304
- Rekruttering
- Shanghai Fifth People's Hospital affiliated to Fudan University
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Shanghai, Kina, 200336
- Rekruttering
- Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
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Shenyang, Kina, 110074
- Rekruttering
- Shenyang Fifth People Hospital
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Shenyang, Kina, 110016
- Rekruttering
- The People's Hospital of Liaoning Province
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Shijiazhuang, Kina, 050004
- Rekruttering
- Hebei Medical University - The Second Hospital
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Zibo, Kina, 255400
- Rekruttering
- Zibo Municipal Hospital.
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Henan
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Zhengzhou, Henan, Kina, 450014
- Rekruttering
- The Second Affiliated Hospital of Zhengzhou University
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Shaanxi
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Xianyang, Shaanxi, Kina, 712000
- Rekruttering
- Yan'an University Xianyang Hospital
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Zhejiang
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Ningbo, Zhejiang, Kina, 315010
- Rekruttering
- The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m^2) for participants with type 2 diabetes mellitus (T2DM)
- BMI ≥28.0 kg/m^2 or BMI ≥24.0 and <28.0 kg/m^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM
- Agreement to adhere to the contraception requirements
Exclusion Criteria:
- History of Type 1 diabetes mellitus (T1DM)
- Obesity induced by other endocrinologic disorders
- Any planned major medical procedure or surgery during the study
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- Any lifetime history of suicide attempt
- History of any hematologic conditions that may interfere with HbA1c measurement
- History of acute or chronic pancreatitis or clinically significant gallbladder disease
- Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization
- Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer
- Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo
Deltakerne vil motta matchende placebo.
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Participants will receive matching placebo via SC injection as per the schedule in the protocol.
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Eksperimentell: Enicepatide Dose 1
Participants will receive enicepatide Dose 1.
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Andre navn:
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Eksperimentell: Enicepatide Dose 2
Participants will receive enicepatide Dose 2.
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Andre navn:
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Eksperimentell: Enicepatide Dose 3
Participants will receive enicepatide Dose 3.
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percent Change From Baseline in Body Weight at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of Participants Achieving ≥5% Body Weight Loss at Week 52
Tidsramme: At Week 52
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At Week 52
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Percentage of Participants Achieving ≥10% Body Weight Loss at Week 52
Tidsramme: At Week 52
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At Week 52
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Percentage of Participants Achieving ≥15% Body Weight Loss at Week 52
Tidsramme: At Week 52
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At Week 52
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Percentage of Participants Achieving ≥20% Body Weight Loss, in Participants Receiving Enicepatide Dose 2 and Dose 3
Tidsramme: At Week 52
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At Week 52
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Change From Baseline in Body Weight at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Waist Circumference at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Fasting Glucose at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Fasting Insulin at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Triglyceride at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Systolic Blood Pressure at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in the Physical Functioning as Assessed by Short Form 36 Health Survey Acute, Version 2.0 (SF-36 v2 Acute) at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Physical Functioning Composite Score as Assessed by Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQoL-Lite-CT) Questionnaire at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Body Weight at Week 52 in GLP-1 RA-based Treatment Naive Populations
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Waist-to-Hip Ratio at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Waist-to-Height Ratio at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Percentage of Participants With Prediabetes at Baseline Achieving Normoglycemia (Hemoglobin A1c [HbA1c] <5.7%) at Week 52
Tidsramme: At Week 52
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At Week 52
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Change From Baseline in Health Related Quality of Life (HRQoL) as Assessed by the SF-36v2 Acute Domain Scores and Component Summary Scores at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in HRQoL as Assessed by the IWQoL-Lite-CT Questionnaire Domain Scores and Total Score at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Non-HDL Cholesterol at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Total Cholesterol at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Free Fatty Acids at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Diastolic Blood Pressure at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Serum Uric Acid at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Percentage of Participants Achieving ≥25% Body Weight Loss at Week 52, in Participants Receiving Enicepatide Dose 2 and Dose 3
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Body Mass Index (BMI) at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Body Weight by Obesity Class at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in HbA1c at Week 52 in Participants With T2DM
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Percentage of Participants With T2DM Achieving HbA1c of <5.7%, ≤6.5% and <7% at Week 52
Tidsramme: At Week 52
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At Week 52
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Change From Baseline in Total Lean Tissue Volume at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Total Lean Tissue Volume at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in Total Adipose Tissue Volume at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Percent Change From Baseline in Total Adipose Tissue Volume at Week 52
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Incidence and Severity of Adverse Events, With Severity Determined According to Mild, Moderate, and Severe Criteria
Tidsramme: Baseline to Safety Follow-Up (55 Weeks)
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Baseline to Safety Follow-Up (55 Weeks)
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Change From Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Change From Baseline in the Patient Health Questionnaire-9 (PHQ-9) Score
Tidsramme: Baseline through Week 52
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Baseline through Week 52
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. juli 2026
Primær fullføring (Antatt)
24. februar 2028
Studiet fullført (Antatt)
15. mars 2028
Datoer for studieregistrering
Først innsendt
22. juni 2026
Først innsendt som oppfylte QC-kriteriene
22. juni 2026
Først lagt ut (Faktiske)
26. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- YC46401
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Nei
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